Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

HIV Prevention Clinical Trial

Official title:

A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499483
• Other study ID #: 1141260-1
• Status: Completed
• Phase: Phase 4
• Start date: January 24, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2022
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)

Description:

Non-randomized, open label single arm trial conducted at Fenway Health as a single site. 100 subjects will be enrolled following a high risk sexual exposure in which HIV exposure is a concern. Each person will be provided with detailed informed consent and if they agree, will receive a 28 day regimen of BIC/F/TAF (Biktary) in a single fixed-dose tablet. Subjects will be seen for 3 visits over a period of four months in which assessments will be done to evaluate safety of product, tolerability of product and HIV status. All subjects will be compared to historical controls in the previous one daily TDF-based nPEP studies which were conducted at Fenway Health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 31, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. > Age of 18 at time of first visit.

2. HIV uninfected

3. Willing and able to provide written informed consent.

4. Willing and able to provide adequate locator information.

5. Willing and able to return to all study visits.

6. Willing to participate in all study procedures.

7. Childbearing age: Willing to use contraception for as long as they are on study medication plus 7 days after. (Appendix A: list of approved contraception).

8. Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. A possible exposure could include:

1. Condomless anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage); or

2. Condomless penile exposure to cervicovaginal secretions or anorectal secretions from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage)

Exclusion Criteria:

1. An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.

2. Pregnancy and/or breastfeeding.

3. People who are actively trying to become pregnant.

4. Acute or chronic hepatitis B infection.

5. Acute or chronic renal disease.

6. Creatinine clearance at or below 30 mL/min (Cockcroft-Gault0 Known intolerance or allergy to tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, or bictegravir.

8. Currently taking or plans to take prohibited medication while enrolled in the study. (Appendix B: complete list of prohibited medications).

9. Non-English speakers.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Drug:
• bictegravir
Single One Pill Formulation of bictegravir, emtricitabine/tenofovir alafenamide (Bictarvy) to be taken once daily orally for a period of 28 days.

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Fenway Community Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nPEP Failure	HIV sero-conversion during study participation following high risk exposure that occured within 72 hours of study product initiation.	4 months active study participation
Primary	Safety and Tolerability assessed as Adverse Events and Safety Lab Evaluation	The following AEs will be evaluated: Diarrhea, Fatigue, Nausea/Vomiting, Headache, Dizziness, Body/Muscle/Joint pain	4 months active study participation
Secondary	Adherence and Acceptability assessed as study product completion rate	Completion of Study Product as Prescribed; Stopped or Modified Study Product, Lost to Follow Up	4 months of active study participation or 28 days of study product use